Sr Director Operations

This is a pivotal leadership role for a proven operations leader who thrives in high-growth environments and has deep expertise in medical device manufacturing. You will build and scale operations from the ground up in our facility to increase volumes from 300 - 5k a month; implementing a robust MRP system, and create distribution networks that will support our company's ambitious growth trajectory.

Manufacturing & Production Leadership

• Develop and implement scalable manufacturing strategies for multiple Class II sterile disposable sterile medical devices.
• Establish strategic manufacturing partnerships and build internal production capabilities
• Build internal production capabilities and evaluate external production capabilities
• Design and optimize production workflows ensuring quality, efficiency, and regulatory compliance. Oversee sterile packaging and device sterilization processes.
• Implement lean manufacturing principles and drive continuous improvement initiatives

  Supply Chain & Systems Development

• Build comprehensive Material Requirements Planning (MRP) systems from inception using NetSuite
• Develop sophisticated inventory management strategies for raw materials, components, and finished goods
• Create demand forecasting models and production planning processes
• Implement supply chain risk management and business continuity plans

  Quality & Regulatory Excellence

• Ensure all manufacturing processes comply with FDA regulations for Class II medical devices
• Maintain ISO 13485, 14971,10555 and 10993 quality management system standards
• Oversee comprehensive quality control and quality assurance programs
• Support regulatory submissions and FDA interactions